EPRO systems validation: Clearly defining the roles of clinical trial teams and ePRO system providers

Value in Health

Volumn 16, Issue 4, 2013, Pages 457-458

  Coons, Stephen Joel ^a  

^a CRITICAL PATH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RUXOLITINIB;

CLINICAL TRIAL (TOPIC); COST CONTROL; DECISION MAKING; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL; SELF REPORT; VALIDATION PROCESS;

CLINICAL TRIALS AS TOPIC; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); SELF REPORT; VALIDATION STUDIES AS TOPIC;

EID: 84879377925     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2013.04.006     Document Type: Editorial

References (14)

1. M.E. Hyland, C.A. Kenyon, R. Allen, and P. Howarth Diary keeping in asthma: comparison of written and electronic methods BMJ 306 1993 487 489
2. A.A. Stone, S. Shiffman, and J.E. Schwartz Patient non-compliance with paper diaries BMJ 324 2002 1193 1194
3. A.L. Ganser, S.A. Raymond, and J.D. Pearson Data quality and power in clinical trials: a comparison of ePRO and paper in a randomized trial B. Byrom, B. Tiplady, ePRO: Electronic Solutions for Patient-Reported Data. Surray 2010 Gower Publishing Limited England
4. R. Tourangeau, and T.W. Smith Asking sensitive questions: the impact of data collection mode, question format, and question context Public Opin Q 60 1996 275 304
5. P.A. Taenzer, M. Speca, and M.J. Atkinson Computerized quality-of-life screening in an oncology clinic Cancer Pract 5 1997 168 175
6. D.E. Bloom Technology, experimentation, and the quality of survey data Science 280 1998 847 848
7. G. Velikova, E.P. Wright, and A.B. Smith Automated collection of quality-of-life data: a comparison of paper and computer touch-screen questionnaires J Clin Oncol 17 1999 998 1007
8. D.M. Bushnell, and M.C. Reilly Validation of electronic data capture of the Irritable Bowel Syndrome - Quality of Life Measure, the Work Productivity and Activity Impairment Questionnaire for Irritable Bowel Syndrome and the EuroQol Value Health 9 2006 98 105
9. Anonymous. AssisTek's ePRO biotech clinical trial data collection saves client $1.6 million over paper questionnaires. PRWeb. October 27, 2008. Available from: http://www.prweb.com/releases/ePRO/clinical-trials/prweb1520734. htm. [Accessed April 9, 2013].
10. Jose N, Langel K. ePRO vs. paper. Applied Clinical Trials Online. June 1, 2010. Available from: http://www.appliedclinicaltrialsonline.com/ appliedclinicaltrials/IT+Articles/ePRO-vs-Paper/ArticleStandard/Article/detail/ 673674. [Accessed April 8, 2013].
11. Koberstein W. Direct to data - an electronic solution to patient diaries. Life Sci Leader. April 2013. Available from: http://www.lifescienceleader.com/ magazine/current-issue-3/item/4242-direct-to-data- - -an-electronic-solution-to- patient-diaries. [Accessed April 9, 2013].
12. U.S. Food and Drug Administration. Guidance for industry - patient-reported outcome measures: use in medical product development to support labeling claims. December 2009. Available from: http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. [Accessed April 5, 2013].
13. A. Gnanasakthy, M. Mordin, and M. Clark A review of patient-reported outcome labels in the United States: 2006 to 2010 Value Health 15 2012 437 442
14. A. Zbrozek, J. Hebert, and G. Gogates Validation of electronic systems to collect patient-reported outcome (PRO) data - recommendations for clinical trial teams: report of the ISPOR ePRO Systems Validation Good Research Practices Task Force Value Health 16 2013 480 489